MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121142

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Metal Related Pathology (4530)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

''us legal mdl'': it was reported that after a right bhr construct was implanted on (b)(6) 2009, plaintiff experienced pain, limited mobility and elevated metal ion levels.A revision surgery was performed on (b)(6) 2019 to treat these adverse events.Details about the surgery are unknown.Plaintiff outcome is unknown.

Event Description

*us legal mdl* it was reported that after a right bhr resurfacing construct was implanted on (b)(6) 2009, the plaintiff experienced pain, limited mobility, metallosis and elevated metal ion levels.A revision surgery was performed on (b)(6) 2019 to treat these adverse events.Both bhr acetabular cup and femoral head were explanted and replaced with competitor¿s devices.Patient recovered from anesthesia uneventfully and transported to the pacu in stable condition.

Manufacturer Narrative

Section a2 and b3 updated due to new information received.

Manufacturer Narrative

D1, d3 and d4 were updated due to new information received.

Manufacturer Narrative

It was reported that a right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the acetabular cup and the femoral head.A review of historical complaints data was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints have been identified for the part number and the reported failure mode, however, as the device is no longer sold, no action is to be taken.As no device batch numbers were provided for investigation, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.The available medical documents were reviewed.The clinical information provided of the elevated metal ion levels, pain, and limited mobility may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

Event Description

It was reported that after a right bhr resurfacing construct was implanted on (b)(6) 2009, plaintiff experienced a fair amount of tingling and numbness, pain, limited mobility, metallosis and elevated metal ion levels.A revision surgery was performed on (b)(6) 2019 to treat these adverse events.Both bhr acetabular cup and femoral head were explanted and replaced with competitor¿s devices.Patient recovered from anesthesia uneventfully and transported to the pacu in stable condition.

Manufacturer Narrative

Additional information: a3, a4, b7, g3 / g4 corrected data: b5, e1, g2, h6, h8.

Manufacturer Narrative

Section h3, h6: it was reported that a right hip revision surgery was performed due to tingling and numbness, pain, limited mobility, metallosis and elevated metal ion levels.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the acetabular cup and the femoral head.A review of historical complaints data was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints have been identified for the part number and the reported failure mode.This will continue to be monitored via routine trending, however it should be noted that the device is no longer sold.The review of the current ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.The available medical documents were reviewed.The patient¿s history of l4-s1 levels discogenic degenerative changes cannot be ruled out as a contributory factor of the reported right leg pain, numbness/tingling, and limited mobility.Per the surgical technique, the acetabular component is to be impacted with 15-20 degrees of anteversion and 40-45 degrees of abduction.However, the primary operative report indicated the surgeon tried to put it in ¿a little less abduction than normal in order to provide more hooding for the valgus femoral head.¿ it is unknown if this position of the acetabular cup has led to increased wear and the reported elevated metal ion levels.Although it was reported the patient¿s metal ion levels were elevated, neither the levels nor the lab reports were provided for review.The revision operative report did not note any findings of metallosis.Based on the information provided, the clinical root cause of the reported clinical symptoms cannot be determined.It cannot be concluded that the reported clinical symptoms were associated with a malperformance of the implant or implant failure.The patient impact beyond the reported pain, numbness/tingling, elevated metal ions and revision surgery cannot be determined.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: RESURFACING FEMORAL HEAD 42MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12537580
• MDR Text Key: 273548798
• Report Number: 3005975929-2021-00444
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 3596010502773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74121142
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2746-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 67 KG